# K151037: GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jul 9, 2015 after 80 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K792022 (1979). 54 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070780: Conmed Linvatec XO Button, Conmed Linvatec (2007) Summary page 4.

## Most influential descendants
- K203259: FairFix Adjustable Button System (2021), 3 descendants of its own
- K223795: FairFix QT Adjustable Button (2023), 0 descendants of its own
- K222169: FairFix Adjustable Button System (2022), 0 descendants of its own
- K221389: FairFix AM Adjustable Button  FairFix PSP Adjustable Button (2022), 0 descendants of its own
- K191204: Infinity Fixation System (2019), 0 descendants of its own

## Indications for use
The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

Source page: https://510kreport.com/device/K151037
Methodology: https://510kreport.com/methodology